Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of teicoplanin in cdad

Conditions: Clostridium Difficile Infection-associated Diarrhea and Colitis

Summary: primary objective: explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with clostridium difficile infection-associated diarrhea and colitis secondary objective: evaluate the safety of teicoplanin in patients with clostridium difficile infection-associated diarrhea and colitis

approximate 10 weeks

Eligibility criteria:
inclusion criteria : * signed informed consent. * male or female no less than 18 years of age. * inpatient with a diagnosis of mild-moderate or severe cdad (first occurrence or first recurrence within 3 months) with: diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (ubm) within 24 hours prior to enrollment, and positive c. difficile toxin test on a stool sample produced within 72 hours prior to enrollment. exclusion criteria: * more than one previous episode of cdad in the 3-month period prior to enrollment. * evidence of life-threatening or fulminant cdad. * likelihood of death within 72 hours from any cause. * history of inflammatory colitides, chronic abdominal pain, or chronic diarrhea * antimicrobial treatment active against cdad administered for \> 24 hours except for metronidazole treatment failures (mtf). * known hypersensitivity or contraindication to teicoplanin. * pregnant or nursing females. * unable or unwilling to comply with all protocol requirements. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparative efficacy of hypertonic saline vs adrenaline nebulization in acute bronchiolitis

Conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus

Summary: the goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. main aim is to evaluate the following in both group of patients 1. improvement in wood-downes clinical score (wdf score) in bronchiolitis 2. length of hospitalization

this is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in pediatrics department combined military hospital nowshera. patients will be divided into two groups randomly. group i patients will be nebulized with drug adrenaline every 6 hours and group ii patients will be nebulized with hypertonic saline every 6 hours. after 24 hours and 48 hours of nebulization, researchers will record wdf score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and spo₂ levels. all data will be recorded on a research performa including length of hospital stay. data will be entered on spss to calculate results. independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. p value less than 0.05 will be considered as significant.

Eligibility criteria:
inclusion criteria: * all children admitted in picu with acute bronchiolitis exclusion criteria: * children with co-exiting illnesses like 1. congenital heart disease 2. immunodeficiency 3. other infectious disease like meningitis, encephalitis, pneumonia, torch 4. kidneys or liver problem 5. seizures

Keywords: wood-downes clinical scoring system
study to assess the safety and effectiveness of beltavac® polymerized with alternaria alternata

Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

Summary: non-interventional study to assess the safety and effectiveness profile of a scit therapy with beltavac® polymerized with alternaria alternata in allergic patients

this prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with beltavac® polymerized in alternaria alternata allergic patients (children and adults) in routine medical care. patients receive a rush schedule administration every month for a year. they attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility criteria:
inclusion criteria: * patients of the age of 5 years and older suffering from a clinically relevant alternaria alternata induced allergic rhinitis * positive skin testing or ige determination to the relevant allergen exclusion criteria: patients suffering from acute or chronic infections or inflammations patients suffering from uncontrolled asthma patients with a known autoimmune disease patients with active malignant disease patients requiring beta-blockers patients having any contraindication for the use of adrenaline
autonomic monitoring in neurocardiogenic syncope

Conditions: Syncope; Chest Pain; Dyspnea

Summary: this is a prospective observational pilot study of suitability of autonomic monitoring via the vu-ams device for prediction of neurocardiogenic syncope (ncs) in children referred to cardiopulmonary exercise testing (cpet) for a diagnosis of syncope. the study population is children referred for cpet to evaluate for neurocardiogenic syncope. the purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the cpet. children presenting for cpet with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.


Eligibility criteria:
inclusion criteria: * parent/legal guardian able to provide informed consent * verbal participant assent * undergoing clinically indicated cpet. * diagnosis of either syncope, chest pain/dyspnea or status post oht * participant willing and able to participate in study procedures * age 7-24 years exclusion criteria: * participant unwilling or unable to participate * contraindication to adhesive placement, eg, epidermolysis bullosa * cancellation of the subject's planned cpet procedure. * tracheostomy tube presence (this will prevent proper placement of impedance cardiogram lead)
prospective cohort study on antibiotic course and efficacy after two-stage revision in pji.

Conditions: Periprosthetic Joint Infection; Anti-Bacterial Agents

Summary: this is a multicenter prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before phase ii revision surgery. eligible patients will be included in this study after signing the informed consent form. after the second stage revision, according to the patient's symptoms and examination results, the attending physician used a reasonable antibiotic treatment scheme (including intravenous and oral medication). all patients voluntarily participated in the study and signed informed consent. during the treatment period, all prospective patients underwent clinical evaluation at the time points of 1, 3, 6, 12, 18 and 24 months after the start of antibiotic treatment after phase ii revision. the infection control rate of patients was evaluated by follow-up at least 2 years after operation, so as to analyze the effect of antibiotic treatment course after two-stage revision of periprosthetic joint infection.

inclusion criteria： 1. a diagnosis of pji was made according to msis criteria 2. received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision. 3. age ≥18 years old 4. the patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. he has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study. exclusion criteria： 1. follow up data were not available; 2. the investigator judged that the patient no longer met the criteria of the study due to compliance problems. recruiting time：2021.10 -2023.10.31 interventions group：no sample size：500 study population description: patients who underwent secondary replantation surgery for prosthetic joint infection at the first affiliated hospital of fujian medical university and other sub-centers were selected.

Eligibility criteria:
inclusion criteria: - 1. a diagnosis of pji was made according to msis criteria. 2. received spacer implantation and a full course of antibiotic treatment (at least 6 weeks), the patient was clinically determined to have infection control and underwent secondary joint revision. 3. age ≥18 years old. 4. the patient voluntarily participated in the study, and was physically and mentally tolerant to the treatment process and various tests of the study. he has signed an informed consent form and passed the examination of all the hospital ethics committees participating in the study. exclusion criteria: * 1. follow-up data not available. 2. researchers judge that patients no longer meet the standards of the study due to compliance problems

Keywords: periprosthetic joint infection second-stage revision anti-bacterial agents
crenobalneotherapy in the treatment of chronic venous insufficiency

Conditions: Balneology

Summary: at 3 months, crenobalneotherapy session is superior to waiting list for patients with chronic venous insufficiency.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 80 years with chronic venous insufficiency regardless of etiology stages 3 or 4 according to the ceap classification (clinical severity, etiology or cause, anatomy, pathophysiology) * patients available to participate in a 3 weeks session in the spa center and to be followed for 6 months exclusion criteria: * pregnant women, * contra-indication for the spa treatment (chronic infectious diseases, cancer, heart failure, serious liver or kidney disease, open leg ulcer, psychiatric disorders, immune deficiency, phlebitis, erysipelas or history of erysipelas); * surgery in the next three months, * spa treatment in the previous 6 months, * professional involvement with a spa resort

Keywords: chronic venous insufficiency varicose vein crenobalneotherapy balneotherapy spa therapy
pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months * treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months * bmi (body mass index) below 39 kg/m\^2 * hba1c (glycosylated haemoglobin) below 12%
comparative safety and clinical performance of dialyzers applied during post-dilution online hemodiafiltration

Conditions: Renal Failure; End Stage Renal Disease

Summary: the clinical investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration

the primary objective of this study is to test whether the new fx p600 (applied during post-dilution online hdf) is non-inferior to two comparator dialyzers (sureflux-17ux (nipro) and polyflux 170 h (baxter/gambro) in removing β2-microglobulin. the secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new fx p600 and the sureflux-17ux as well as the polyflux 170 h membranes. additionally, the safety of the fx p600 dialyzer with a modified polysulfone membrane will be investigated.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years * existing informed consent form signed and dated by study patient as well as investigator/authorized physician * the patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare his consent for participation in the clinical trial * patients with a chronic kidney disease stage 5d (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy exclusion criteria: * any condition which could interfere with the patient's ability to comply with the study. this decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.). * ongoing participation in an interventional clinical study during the preceding 30 days * previous participation in this study * pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or lactation period * patient is not able to give informed consent

Keywords: hemodialysis hemodiafiltration renal replacement therapy
the effectiveness of virtual reality training program

Conditions: Alzheimer Disease

Summary: alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. advanced age is a significant risk factor for ad. virtual reality (vr) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. vr technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). the aim of our study was to examine the effect of the virtual reality training program on cognition in individuals with alzheimer's disease living in the community.

the aim of our study was to examine the effect of the virtual reality training program on cognition in individuals with alzheimer's disease living in the community. prospective randomized controlled single blind study after the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only.

Eligibility criteria:
inclusion criteria: * ≥ 55 years and older diagnosed with ad according to dsm-iv diagnostic criteria by a neurologist, moca ≥ 16 clinical dementia rating scale \< 2 exclusion criteria: * various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) clinically significant aphasia (must be able to understand the therapist's commands) significant visual or sensory impairment
study to evaluate safety, tolerability, pk and the food effect on pk of asc11/rtv tablets in healthy subjects

Conditions: Healthy; COVID-19

Summary: this is a randomized, double-blind, placebo-controlled phase i clinical study evaluating the safety, tolerability, and pharmacokinetics of asc11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study evaluating the effect of food on the pharmacokinetics of asc11 plus ritonavir tablets


Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged 18-60 years (including boundary values) * if a woman has no planned pregnancy within 6 months after signing the informed consent, and is willing to use effective contraception (e.g. condom, uterine cap, non-hormonal intrauterine device \[iud\]) for at least 3 months from the first administration of the study intervention to the last administration of the study intervention; or not fertile (e.g. surgical sterilization \[bilateral oophorectomy, tubal ligation, or hysterectomy\] or natural sterilization \[continuous \> 12 months without menstruation\]) * if male, agree to use effective contraception throughout the study intervention and for at least 3 months after the last dose of the study intervention, and do not donate sperm. * general good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments. * able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent. exclusion criteria: * pregnant and lactating women. * patients with acute or chronic diseases, including but not limited to cardiovascular, digestive, respiratory, urinary, nervous, endocrine, immune, musculoskeletal, and skin conditions, were judged by the investigator. * any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease. * previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis. * have an autoimmune disease, immunosuppression, or any form of immune deficiency.

Keywords: covid-19 asc11 3cl-pro
the efficacy of inquiry based stress reduction (ibsr) for depression, a clinical trial

Conditions: Depression

Summary: background: major depression is a common mental disorder with serious consequences. the societal costs of depression are high. despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. improvement of existing treatments or development of new and better treatments is badly needed. inquiry based stress reduction (ibsr) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression. objective: the objective of the current study is to assess the effectiveness of ibsr. research to date has shown that ibsr is effective in reducing symptoms of anxiety and depression. the investigators want to know if ibsr is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (cbt). the investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies. study design: a randomized controlled intervention study. study population: 88 patients with a mild to moderate depression as their principal diagnosis. intervention: ibsr or cbt


Eligibility criteria:
inclusion criteria: * aged 18 years and older, * not making use of other treatment for depression at the time, * no history of psychotherapy in the last year, * no medication for depression or unchanged dosage of medication during the last two months , * all participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout), * all participants must have at least a low average level of intelligence (iq above 80). during regular intakes a clinical judgment is made. this is in accordance with the standard protocols used within the fortagroep. * all participants are required to have sufficient knowledge of the dutch language. exclusion criteria: * active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the bdi-ii at pre-treatment: if patients marked the statement ''i would kill myself if i could'', they are classified as being at risk of suicide) * if the dsm-iv criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met * a mental impairment or neurocognitive disorders such as alzheimer * substance abuse requiring specialist treatment * no time for homework.

Keywords: depression treatment ibsr cbt
new technologies for endoscopic treatment of bleeding gastroduodenal ulcers

Conditions: Ulcer Hemorrhage

Summary: the purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-a.

the clinical study was conducted on the basis of the voronezh city specialized center for the treatment of patients with gastrointestinal bleeding. the study included 112 patients with ulcerative gastroduodenal bleeding. all patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). in the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-a and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (patent russian federation (rf) № 2632771). in the comparison group (55 people), traditional methods of endoscopic hemostasis were used.

Eligibility criteria:
inclusion criteria: * gastroduodenal ulcers with bleeding exclusion criteria: * bleedings of other etiology

Keywords: ulcer bleeding treatment aseptisorb-a
study of rapastinel as monotherapy in patients with mdd

Conditions: Depressive Disorder, Major

Summary: the study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of rapastinel, compared to placebo in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at visit 1 * treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: * schizophrenia spectrum or other psychotic disorder * bipolar or related disorder * major neurocognitive disorder * neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study * dissociative disorder * posttraumatic stress disorder * mdd with psychotic features * significant suicide risk, as judged by the investigator

Keywords: depression
effect of alveolar recruitment maneuver on postoperative pain

Conditions: Pain, Postoperative

Summary: control group: no additional procedure low arm group : recruitment maneuver of 30cmh2o high arm group: recruitment maneuver of 60cmh2o

after random assignment of group, control group: no additional procedure apply, low arm group : after surgical trocha out after bariatric surgery, applying 30cmh2o recruitment maneuver 5 times every 5 seconds, high arm group: after surgical trocha out after bariatric surgery, applying 60cmh2o recruitment maneuver 5 times every 5 seconds

Eligibility criteria:
inclusion criteria: * patients who scheduled for elective bariatric surgery exclusion criteria: * uncontrolled cardio-vascular disease, active pulmonary disorder